Trials / Completed
CompletedNCT01305824
A Study of PRT-201 Administered Immediately After Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease
Multicenter, Double-Blind, Placebo-Controlled Study of PRT-201 Administered Immediately After Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 151 (actual)
- Sponsor
- Proteon Therapeutics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine if PRT-201 when applied to a limited segment of your blood vessel (about 2 inches) immediately after surgery to create an arteriovenous fistula is safe and improves the patency of your fistula. PRT-201 is a protein that has been shown to help keep vessels open ("patent") when applied to the outside surface of the blood vessels (arteries and veins) in AVF patients in a previous study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PRT-201 | PRT-201 10 micrograms administered at the time of AVF creation. |
| DRUG | Placebo | Placebo administered at the time of AVF creation. |
| DRUG | PRT-201 | PRT-201 30 micrograms administered at the time of AVF creation. |
Timeline
- Start date
- 2011-03-01
- Primary completion
- 2012-11-01
- Completion
- 2012-11-01
- First posted
- 2011-03-01
- Last updated
- 2015-04-30
Locations
23 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01305824. Inclusion in this directory is not an endorsement.